Tuesday, 1 October 2019

Questions (380)

Brendan Griffin


380. Deputy Brendan Griffin asked the Minister for Health his views on a matter (details supplied) regarding mandatory vaccination; and if he will make a statement on the matter. [39616/19]

View answer

Written answers (Question to Health)

Immunisation is regarded as one of the safest and most cost-effective of all health care interventions.  It is also one of the most effective ways a parent can protect the health of their child.  The childhood immunisation programme in Ireland has had a huge impact in improving the health of the Irish people.  Diseases that used to be common in this country and around the world such as polio, measles, diphtheria, whooping cough and many other serious infectious diseases are now preventable by vaccination.  However, due to misinformation vaccination rates are not as high as they should be.

One of my priorities as Minister for Health is to increase vaccination rates across the country and I am exploring several options in this regard.  I launched the Vaccine Alliance on the 10 September whose aim is to increase uptake rates of childhood vaccines and reduce vaccine hesitancy.  The group includes a wide range of organisations and further organisations will be added once the terms of reference, key target audiences, and priorities for the Vaccine Alliance have been agreed.  It is important to note that vaccine hesitancy is not unique to Ireland.  It is a global issue and has been identified by the World Health Organisation as one of the ten leading threats to global health in 2019.

As you are aware the immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC).  NIAC is a committee of the Royal College of Physicians of Ireland comprising of experts in several specialties including infectious diseases, paediatrics and public health.  The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation.  It makes recommendations on vaccination policy to my Department.  NIAC continues to revise recommendations to allow for the introduction of new vaccines in Ireland and to keep abreast of changes in the patterns of disease.  Therefore, the immunisation schedule will continue to be amended over time. 

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland.  The HPRA and the European Medicines Agency (EMA) continually monitor adverse events to vaccination.  The HPRA operates a national adverse reaction reporting system, which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to.  All Reports received by the HPRA are routinely transmitted to the EMA's adverse reaction database for inclusion in global signal detection and monitoring activities. 

I am informed that as all vaccines used in Ireland’s immunisation programmes have been approved for use in the European Union by the EMA there is no requirement for indemnity to be provided to vaccine manufacturers.

Aluminium has been used in vaccines for many decades to improve the body's response to vaccination.  It is a component of the HPV vaccine Gardasil and several other vaccines.  The World Health Organisation's (WHO) Global Advisory Committee on Vaccine safety (an expert clinical and scientific advisory body) has concluded that there is no evidence of a health risk from aluminium-containing vaccines.

I am also informed by the HPRA that there is no thiomersal in any of the vaccines used in the childhood immunisation programme in Ireland.

My Department has been advised by the HPRA that at present there are three types of vaccine strains authorised in IE which are manufactured in cell lines which were originally derived from foetal tissue.  The Rubella vaccine strain is produced in the Wistar RA 27/3 cell line while the hepatitis A and varicella vaccine strains are expressed in the MRC-5 human diploid cell line.  No new foetal tissue has been used in the manufacture of either rubella, hepatitis A or varicella antigens since the development of the original cell lines.  Following production, the vaccines are purified from the cell line expression system and the purity of the vaccine formulation has to be demonstrated in line with regulatory standards.  This includes limiting process-related impurities derived from the manufacturing process i.e. the cell expression system (e.g. host cell proteins, host cell DNA).  The WHO has concluded that levels of up to 10 ng of residual host cell DNA can be considered as acceptable.

Prior to use in humans all vaccine formulations undergo preclinical testing.  These typically involve a range of in vitro tests followed by a comprehensive range of toxicity studies in animals.  These studies identify potential safety concerns and serve to avoid possible harm to human subjects.  Clinical safety studies are conducted during the clinical trials and the safety data that is collected is based on events reported after each dose of vaccine and also events reported after a longer time post-vaccination.  Clinical trials run for a defined period and safety data will be collected from trial participants for a defined period post vaccination.  This period of time may differ between trials.  In addition, vaccines on the market are continuously monitored to provide additional safety data and to identify adverse reactions.  Under the regulatory framework, benefit-risk evaluations continue to be carried out throughout the product lifecycle.

Manufacture of vaccines must also comply with good manufacturing standards and regulatory requirements in EU and national legislation to ensure that the materials and methods used are appropriate.  Vaccine manufactures are subject to independent assessment and inspection by national medicines agencies.  It is important to reiterate that all medicines, including vaccines are subject to on-going review and evaluation of all available data from a range of sources, including systematic scientific literature review, to consider any impact that their data may have on the overall assessment of the benefits and risks of a medicinal product.  The safety of these vaccines continues to be monitored at EU level through the EMA and its expert committees, which includes representatives from member state competent authorities such as the HPRA.